Using one-on-one peer mentors to help patients with a spinal cord injury transition from rehabilitation to home / Mark L. Laudenslager.

Format:

Book

Author/Creator:

Laudenslager, Mark L., author.

Language:

English

Subjects (All):

Caregivers--Psychology.

Caregivers.

Outcome assessment (Medical care).

Quality of life.

Physical Description:

1 online resource (75 pages) : illustrations, maps

Place of Publication:

Washington, DC : Patient-Centered Outcomes Research Institute (PCORI), 2020.

Summary:

BACKGROUND: We have shown that our PsychoEducation, Paced Respiration, and Relaxation (PEPRR) intervention reduces caregiver psychological distress. Less distressed caregivers may contribute to better quality of life (QOL) in their patients; however, empirical evidence supporting this link is lacking. OBJECTIVE: Scientific aims included the following: (1) Assess the impact of PEPRR-2.0 on patient QOL as primary patient outcome; (2) assess the impact of PEPRR-2.0 on caregiver distress as primary caregiver outcome; and (3) assess biomarkers of chronic stress in caregivers. METHODS: We recruited patients receiving allogeneic hematopoietic stem cell transplants (Allo-HSCT) and their caregivers from a private hospital and an academic medical center. We randomized caregivers to either stress management intervention (PEPRR-2.0) or enhanced treatment as usual (eTAU; that is, they received written materials provided to PEPRR-2.0 as well as a check-in call). A Master's degree-level social worker delivered 10 one-on-one PEPRR-2.0 sessions to caregivers over 3 months. Primary outcomes were patient QOL (Functional Assessment of Cancer Therapy-Bone Marrow Transplant [FACT-BMT]) and a composite measure of caregiver distress (CG-Distress) based on the first principal component (PC) of a PC analysis (PCA) that included depression, anxiety, and stress questionnaire scores. Secondary outcomes included individual measures comprising the PCA, caregiver burden, and biomarkers of caregiver stress (hair cortisol, telomere length [TL], and telomerase activity [TA]). Hair cortisol is a retrospective measure of activity of the hypothalamic pituitary adrenal axis; TL and TA also track influences of chronic stress. We obtained outcomes at the time of transplant as well as at 6 weeks, 3 months, and 6 months following transplant. Hierarchical linear models tested intervention group, time, and interactions as fixed effects and participant as a random effect; we analyzed caregiver outcomes similarly. RESULTS: A total of 155 caregiver/patient dyads comprised an intent-to-treat sample. Patients and caregivers were worse than psychological norms before transplant. Randomization was effective (no baseline differences in psychological or demographic measures between groups). Patients whose caregivers were randomized to PEPRR-2.0 did not show a difference in QOL from baseline to 6 months (mean change = +3.74; 95% CI, −3.54 to 11.02) relative to patients whose caregivers were randomized to eTAU (mean change = +3.16; 95% CI, −2.88 to 9.20) based on the FACT-BMT. CG-Distress in those receiving PEPRR-2.0 decreased significantly from baseline to 6 months (mean decrease = −0.23; 95% CI, −0.448 to −0.010) compared with eTAU (mean increase = +0.27; 95% CI, 0.033-0.504), confirming the positive effect of PEPRR-2.0 (effect size = 0.51) on CG-Distress. Biomarkers were unrelated to pretransplant distress in either caregivers or patients. We found no impact of the intervention on caregiver biomarkers. CONCLUSIONS: PEPRR-2.0 reduced CG-Distress without influencing patient QOL. Neither distress at baseline nor intervention affected biomarkers. The short duration of intensive caregiving may have contributed to a lack of effect of caregiving on biomarkers. LIMITATIONS: This study focused only on Allo-HSCT patients and caregivers. Total FACT-BMT may not have been sensitive to changes in patient psychological QOL. We also failed to meet recruitment goals in the period allowed by the PCORI contract, reducing statistical power.

Contents:

ABSTRACT 4

BACKGROUND 6

Objectives/Aims 9

Figure 1 Conceptual Model Relating Patient and Caregiver 10

PARTICIPATION OF PATIENTS AND OTHER STAKEHOLDERS 11

METHODS 14

Study Overview 14

Study Design 14

Participants 15

Intervention 15

Comparator 17

Study Outcomes and Data Collection 17

Figure 2 Time Frame From the Participant's Perspective 22

Study Setting 22

Time Frame for the Study 22

Analytical and Statistical Approaches 23

Protocol Changes 25

RESULTS 27

Recruitment 27

Figure 3 Regional Distribution of Patients and Caregivers by County Within

States (Color Reflects Density Based on Scale) 28

Baseline Demographics and Outcome Relationships 29

Figure 4 CONSORT Diagram 30

Table 1 Patient Characteristics 31

Table 2 Caregiver Characteristics 33

Table 3 Means (95% CIs) for Primary and Secondary Outcomes at Baseline With

Group Comparisons (N = 155) 35

Figure 5 Pretransplant Box-and-Whisker Plots for Patient (Gray) and Caregiver

(Open) Compared With Clinical Cutoff or Population Mean 36

Table 4 Pearson Correlations for Within Patient (N = 148 a) and Caregiver (N =

149 a) at Baseline 38

Table 5 Pearson Correlations Between Patient and Caregiver Psychological

Measures at Baseline (N = 155 a) 39

Figure 6 Pretransplant Psychological Characteristic Comparison for Patients and

Caregivers 40

Figure 7 Caregiver hCORT Concentration, by Psychological Measures 41

Figure 8 Caregiver TL and TA, by age 42

Primary Outcomes 43

Figure 9 Primary Outcomes for Patients (A) and Caregivers (B) 44

Table 6 Estimates and Test Results From Mixed-Model Analyses of Covariance

for Primary and Secondary Outcomes and Composite Scores 45

Secondary Outcomes 47

Adverse Events 48

DISCUSSION 49

Context for Study Results 49

Generalizability of the Findings 50

Implementation of Study Results 51

Subpopulation Considerations 52

Study Limitations 52

Figure 10 Time Anchors for hCORT and Psychological Outcomes 53

Future Research 54

CONCLUSIONS 55

REFERENCES 56

RELATED PUBLICATIONS 67

ACKNOWLEDGMENTS 69

APPENDIX 70

Appendix A Community Advisory Board Meeting Summary Highlights 70.

Notes:

Description based on publisher supplied metadata and other sources.

Includes bibliographical references.